FDA Inspection
Pacific BioLabs, Inc.Pacific BioLabs, Inc. – FDA Inspection, Mar 19, 2018
Record Details
This FDA Inspection record concerns Pacific BioLabs, Inc., with an inspection on March 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8dcadb58-d9f1-4628-b48b-37b934536f10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046565
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pacific BioLabs, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2026 | Not classified | San Francisco District Office | Drug Quality Assurance |
| July 18, 2025 | Not classified | San Francisco District Office | |
| June 1, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2018 | Not classified | San Francisco District Office | |
| October 27, 2017 | Not classified | San Francisco District Office |
Other documents for Pacific BioLabs, Inc.
- FDA Inspection 1337886 - 2026-09-25
- FDA Inspection 1277213 - 2025-07-18
- FDA Inspection 1206864 - 2023-06-01
- FDA Inspection 1046401 - 2018-02-22
- FDA Inspection 1040908 - 2017-10-27
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